Hip joint recalls

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Inter-Op Hip Shell Implant Recall

Sulzer Orthopedics, Inc. is the fourth largest supplier of orthopedic implants for hips, knees and shoulders in the world. They recalled their Inter-Op acetabular shell for hip implants on December 8, 2000. The Inter-op hip shell was first introduced in 1996. The problem products were primarily sold after October 1999, although there were certain lots affected that were sold as early as July 1997. Sulzer estimates that approximately 17,500 persons have been implanted with the problem hip shell, and that 90% of these persons are located within the United States.

The recall involves the Inter-Op acetabular hip shell implant. The hip implant is actually a component system designed to replicate the ball-and-socket structure of the hip joint when total replacement is required. The hip shell is part of the component system. Apparently, unacceptable levels of an oil-based lubricant left on the hip shells after manufacturing prevented the implant from bonding with the hip bone. As a result, the hip implant slips out of position and a second hip replacement surgery becomes necessary. Individuals typically show signs of loosening within the first three months after surgery. Symptoms characteristic of loosening are hip and joint pain, inability to bear weight on the hip and x-rays showing the migration or separation of the implant from the hip bone.